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CRF Design in CT
CDM
| Question | Answer |
|---|---|
| CRF Definition | Data entry from patient data (normally for ONE patient) |
| ICH GCP: CRF Design | Documentation and filling version controlled, QC |
| ICH GCP: CRF Fill out | By investigator only, incl. approval of all changes |
| CRF Design Concepts | pCRF IVRS/IWRS pCRF/iCRF eCRF (EDC) |
| CRF Design: pCRF | Paper CRF, predominant data entry method in Ct of all phases |
| CRF Design: IVRS/IWRS | Interactive voice/web response system Used for randomization, study drug ordering, SD distribution, patient diaries, process tracking |
| CRF Design: iCRF | Scanning, Reading, Verification |
| What are the functions & impact of the CRF? | * method for structured data collection *Determines the course of the study *Key role for structuring activities *Mainspring foe the whole study conduct |
| List some CRF target groups | Study staff Patients Medical staff at CRO CRAs data Management Team Statistics MW RA Quality assurance Quality management drug Safety |
| What is the relationship between the protocol and the CRF? | The CRF is developed according to the protocol of the CT to reflect the need of the protocol in collecting the appropriate data for eact study subject. |
| What are the four sections of the protocol that are especially relevant for CRF development? | -study flowchart/ visist schedule -Inclus./Exclus. criteria -Study Procedures (Methods) -Safety & Efficacy Data |
| What are the technical requirements for CRF design? | -Capable workstation -Large/ High resolution monitor -DTP program -Printer -Drivers for keyboard + printer -Fonts -Applications/ Tools -Training |
| Basic CRF design principles | -Distinct identifiers -Instruction for Data Collection -Simple Phrasing -Detailed Incl./Excl. Criteria -Consider global studies (language:English) -Clear Structure -Easy to fill out -Chronological CRF pages -Short & definite |
| Basic CRF design principles Cont. | -Avoid duplicate data collection -PI date and Signature mandatory |
| Potential pitfall in CRF design? | -Merging data fields in one single page -Splitting info over 2 or more pages -unusual phrases or abbreviations -Calculation of CRF forms |
| Things to Consider during CRF Review? | WHY: evaluability of collected data WHO: Target groups WHEN: After protocol final & Before site initiation HOW: read protocol, make notes, comments, reasons for change |
Created by:
marlice
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